Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT01479660
Status:
UNKNOWN
Last Update Posted:
2011-11-24
First Post:
2011-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Healthy Bacteria in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-23', 'studyFirstSubmitDate': '2011-11-22', 'studyFirstSubmitQcDate': '2011-11-23', 'lastUpdatePostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of at least 3 points in the D.A.I i.e. Reduction in the activity score of inflammation from the baseline value at 12 weeks.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Reduction in intestinal permeability', 'timeFrame': '12 weeks'}, {'measure': 'Reduction in faecal and serum inflammatory markers', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Probiotics', 'ulcerative colitis', 'inflammatory bowel disease'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'Intestinal inflammation seen in inflammatory bowel disease (IBD) results from an altered mucosal immune response to luminal bacterial antigens. Current research suggests that an inappropriate and persistent immune response against commensal intestinal bacterial flora plays a pivotal role in the pathogenesis of chronic Inflammatory Bowel Disease (IBD). It has been also proposed that the signs and symptoms of IBD may be mediated by the increased intestinal permeability secondary to low grade inflammation in the gut mucosa. Increased intestinal permeability results in further exposure of underlying intestinal mucosa to luminal bacteria and antigens perpetuating the intestinal inflammation. Thus restoring intestinal permeability rather than only reduction of mucosal inflammation would thus be a desirable endpoint in the restoration of mucosal integrity and would be the harbinger of better long term outcome. Many clinical trials have shown that probiotics may have beneficial effect on IBD patients. Probiotics are hypothesized to work by several mechanisms though they are not clearly established. The role of probiotics in improving intestinal permeability has not been evaluated. The probiotic VSL #3 is easily available, cheap, effective and safe alternative or substitute for the existing therapeutic agents will be evaluated in this study for their efficacy, tolerability, compliance in inducing clinical response in patients with Ulcerative colitis. This will be a double blind randomized placebo controlled study to determine the clinical efficacy of 12 weeks of oral probiotics (VSL#3) in patients with inflammatory bowel disease. The objectives of this study are to determine the efficacy of probiotics on clinical endoscopic and histological improvement, to find the improvement in faecal, serum and intestinal tissue inflammatory markers, improvement in intestinal permeability, improvement in Quality of life parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Active disease at presentation\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Any patient who has received probiotic in the preceding 4 weeks\n* Patient with life threatening cardiac, renal, pulmonary or cardiovascular disease\n* Inability to obtain the informed consent\n* Severe disease requiring hospitalization / steroids/ anti-cytokine therapy\n* Patient taking aspirin and other antiplatelet drugs\n* Patient with uncontrolled diabetes\n* Patient with Gall stone disease\n* Patient currently on antibiotic,NSAIDs or indigenous medicine'}, 'identificationModule': {'nctId': 'NCT01479660', 'briefTitle': 'Role of Healthy Bacteria in Ulcerative Colitis', 'organization': {'class': 'UNKNOWN', 'fullName': 'PIMERIndia'}, 'officialTitle': 'Probiotic for the Restoration of Intestinal Permeability and Reduction of Intestinal Inflammation in Active Ulcerative Colitis: A Double Blind Randomized Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '11/6095 dated 15/03/2011'}, 'secondaryIdInfos': [{'id': 'CTRI/2011/08/001944', 'type': 'REGISTRY', 'domain': 'Clinical Trials Registry- India'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'interventionNames': ['Drug: Probiotic']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'description': 'Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose', 'armGroupLabels': ['Control']}, {'name': 'Probiotic', 'type': 'DRUG', 'description': 'Probiotic Capsules (450 billion CFU) will be orally administered daily for a period of 12 weeks and Probiotic in higher dose of (3600 billion CFU) will be administered daily for a period of 12 weeks', 'armGroupLabels': ['Probiotic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Bikash Medhi, MD', 'role': 'CONTACT', 'email': 'drbikashus@yahoo.com', 'phone': '+91-1722755250'}, {'name': 'Rakesh Kochhar, MD, DM', 'role': 'CONTACT', 'email': 'dr_kochhar@hotmail.com', 'phone': '+91-1722756608'}, {'name': 'Bikash Medhi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rakesh Kochhar, MD,DM', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Usha Dutta, MD, DM', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pallab Ray, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kaushal K Prasad, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Chetana Vaishnavi, Ph.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kartar Singh, MD, DM', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Post Graduate Institute of Medical Education and Research', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'centralContacts': [{'name': 'Bikash Medhi, MD', 'role': 'CONTACT', 'email': 'drbikashus@yahoo.com', 'phone': '+91-1722755250'}, {'name': 'Rakesh Kochhar, MD, DM', 'role': 'CONTACT', 'email': 'dr_kochhar@hotmail.com', 'phone': '+91-1722756608'}], 'overallOfficials': [{'name': 'Bikash Medhi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology, India', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Additional Professor, Department of Pharmacology', 'investigatorFullName': 'Dr. Bikash Medhi, MBBS, MD(AIIMS),MAMS,FIMSA', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}